Purple Book product · Reference 351(a)
Herceptin
trastuzumab
At a glance
Sep 25, 1998
Approved
Reference 351(a)
License type
Disc*
Marketing
Yes
Patents listed
Key dates
Approval
Approval date of this BLA submission.
Sep 25, 1998
28 yr 1 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Oct 20, 2017
8 yr 9 mo ago
Today
Pharmaceutical detail
Strength
420MG
Dosage form
For Injection
Route
Intravenous
Presentation
Multi-Dose Vial
Center
CDER
License number
1048
Product number
001
Submission type
Original
Supplement number
Not listed
Change type
Not listed
Reference product family
View full familyThis is the reference (originator) product. Biosimilars and interchangeables referencing it are listed below.
- 2017HerceptinReference 351(a)
trastuzumab · Genentech, Inc.
- 2019KanjintiBiosimilar 351(k)
trastuzumab-anns · Amgen Inc.
- 2019KanjintiBiosimilar 351(k)
trastuzumab-anns · Amgen Inc.
- 2017OgivriBiosimilar 351(k)
trastuzumab-dkst · Biocon Biologics Inc.
- 2019OgivriBiosimilar 351(k)
trastuzumab-dkst · Biocon Biologics Inc.
- 2019OntruzantBiosimilar 351(k)
trastuzumab-dttb · Samsung Bioepis Co., Ltd.
- 2020OntruzantBiosimilar 351(k)
trastuzumab-dttb · Samsung Bioepis Co., Ltd.
- 2018HerzumaBiosimilar 351(k)
trastuzumab-pkrb · CELLTRION, Inc.
- 2019HerzumaBiosimilar 351(k)
trastuzumab-pkrb · CELLTRION, Inc.
- 2019TrazimeraBiosimilar 351(k)
trastuzumab-qyyp · Pfizer Ireland Pharmaceuticals Unlimited Company
- 2020TrazimeraBiosimilar 351(k)
trastuzumab-qyyp · Pfizer Ireland Pharmaceuticals Unlimited Company
- 2024HercessiBiosimilar 351(k)
trastuzumab-strf · Accord BioPharma Inc.
Patent list (4)
Taxonomy and ontology
12 termscenter
Center for Drug Evaluation and Research
center · CDER
application pathway
Biologics License Application
blaNumber · BLA
license type
351(a)
blaType · 351(a)
application pathway
Section 351(a) Biologic
blaType · 351(a)
product role
Reference or Standalone Biologic
blaType · Reference product
marketing status
Discontinued
marketingStatus · Disc*
licensure status
Licensed
licensure · Licensed
route
Intravenous
routeOfAdministration · Intravenous
dosage form
For Injection
dosageForm · For Injection
source kind
Monthly Download
sourceKind · monthly_download
- Food and Drug Administrationparent ofCenter for Drug Evaluation and Research
- Food and Drug Administrationsource forMonthly Download
- Biologics License Applicationparent ofSection 351(a) Biologic
- Biologics License Applicationparent ofSection 351(k) Biosimilar or Interchangeable
- Section 351(a) Biologicmaps to351(a)
- 351(a)classifiesReference or Standalone Biologic
Source provenance
